Coronary Artery Bypass Grafting, Coronary Artery Disease, Surgical Site Infection
Conditions
Keywords
CABG, Left Internal Mammary Artery, Skeletonized Harvesting
Brief summary
The COMFORT Trial is a randomized controlled superiority trial comparing skeletonized (SK) versus non-skeletonized (non-SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft in patients undergoing isolated coronary artery bypass grafting (CABG).
Detailed description
The COMFORT trial is an international, multicentre, blinded, expertise-based randomized controlled trial evaluating two commonly used techniques for harvesting the left internal mammary artery (LIMA) during coronary artery bypass grafting (CABG): skeletonized and non-skeletonized (pedicled) harvesting. Although skeletonized harvesting has been associated with reduced sternal wound complications and postoperative pain, concerns have emerged regarding its potential impact on graft patency and long-term cardiovascular outcomes. Existing evidence is largely derived from observational studies and post hoc analyses, and no adequately powered randomized trial has prospectively compared these techniques using systematic imaging-based graft assessment. The COMFORT trial will enroll approximately 1,116 patients undergoing isolated CABG with a planned LIMA-to-LAD graft. Participants will be randomly assigned to undergo either skeletonized or non-skeletonized LIMA harvesting performed by surgeons experienced in both techniques. Participants and outcome assessors will remain blinded to treatment allocation. Participants will undergo protocol-mandated coronary computed tomography angiography (CTA) at 1.5 years after surgery, with follow-up extending to 2 years. Independent blinded committees and a central CTA core laboratory will adjudicate imaging and clinical outcomes. In addition to graft assessment, the study will evaluate the effects of harvesting technique on cardiovascular outcomes, sternal wound complications, chronic postoperative pain, quality of life, and healthcare resource utilization. The findings of COMFORT are expected to provide definitive evidence to guide surgical practice and inform future guidelines regarding the optimal method of internal mammary artery harvesting during CABG surgery.
Interventions
PROCEDURESkeletonized LIMA Harvesting
Skeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves
PROCEDURENon-Skeletonized LIMA Harvesting
Non-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)
Sponsors
Hamilton Health Sciences Corporation
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, data collectors, research coordinators, outcome adjudicators, CTA core laboratory readers, and statisticians are blinded to treatment allocation. Only the operating surgeon and operating room staff are aware of the assigned harvesting technique. CTA images are de-identified prior to core laboratory review, and outcome adjudication is performed by blinded independent committees.
Intervention model description
Participants will be randomized to undergo either skeletonized or non-skeletonized LIMA harvesting during CABG surgery and followed prospectively for comparison of graft patency, clinical outcomes, wound complications, pain, and quality of life between the two parallel treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft 3. Provision of written informed consent
Exclusion criteria
1. Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy) 2. Emergency surgery (defined as surgery required within 24 hours of presentation) 3. History of prior sternotomy 4. Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery 5. History of chronic sternal pain prior to the index surgery 6. Known left subclavian artery stenosis (\>50%) 7. Previous radiation therapy to the chest 8. Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication 9. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² at baseline (relative contraindication to CTA contrast) as determined based on each centre's laboratory standard. 10. Known pregnancy or plans for pregnancy during the study period 11. Life expectancy less than 1.5 years due to non-cardiac conditions 12. Inability or unwillingness to comply with follow-up procedures including CTA at 1.5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Graft Patency | 1.5 years after surgery | Binary assessment of LIMA-LAD graft patency versus graft failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 2 years after surgery | The composite of cardiovascular mortality, myocardial infarction, or repeat revascularization |
| Number of Participants with a Sternal Surgical Site Infection | 90 days after surgery | The composite of sternal surgical site infection |
| Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion | 2 years after surgery | Any coronary revascularization procedure (PCI or CABG) targeting the LIMA-LAD graft territory, or occlusion of the LIMA-LAD graft revealed by clinically indicated coronary angiography or CTA |
Contacts
PRINCIPAL_INVESTIGATORAndre Lamy, MD
Population Health Research Institute
Outcome results
None listed